StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Nova StatStrip A Glucose/Creatinine Meter System
研究概览
简要总结
The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician.
详细描述
To assess the performance of the StatStrip A Glucose/Creatinine assay in the hands of lay users on capillary whole blood obtained by finger stick and compare with the performance characteristics to a central laboratory traceable reference method.
To assess the Ease of Use of the StatStrip Glucose / Creatinine Meter System in the hands of the intended lay users. Lay users will be provided with all package insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the lay users other than clarifying the protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects (≥ 18 years old) with diabetes.
- •Adult subjects (≥ 18 years old) with kidney diseases (CKD, ESRD) and/or in dialysis.
- •Adult subjects (≥ 18 years old) that are healthy.
- •Subjects willing to complete all study procedures.
- •Subjects whose pre-screen glucose or creatinine medical history is deemed of value by the study site
- •Subjects able to read, write, speak in English.
排除标准
- •Subjects unable to consent to participating in the study.
- •Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
- •Subjects taking prescription anticoagulants (such as Warfarin or Heparin) or has clotting problems that may prolong bleeding.
- •Subjects having hemophilia or any other bleeding disorder.
- •Subjects having an infection with a blood borne pathogen (e.g. HIV, hepatitis).
- •Subjects working for a medical device or diagnostic company.
结局指标
主要结局
Nova StatStrip A Glucose/Creatinine Meter System
时间窗: 20 days
The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician. The two parameters for the outcome measure in this study are glucose and creatinine. The unit of measure for glucose and creatinine is mg/dL and mmol/L, respectively.
次要结局
未报告次要终点